Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal (incl Obstetrics), Intraoperative, Transurethral, Neurosurgery, Pediatrics, Transrectal, Small Parts (organ

Device Description

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the B-K Medical Ultrasound Scanner Flex Focus 1202 (K132335), based on the provided text.

Important Note: This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a de novo approval requiring extensive clinical validation of novel performance characteristics. The "device performance" in this context mainly refers to adherence to safety and performance standards already established for ultrasound systems, and the new features (RF wireless, Vector Flow Imaging) are discussed in terms of their safety and equivalence, not necessarily extensive clinical efficacy trials.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Acoustic Output	Ispta ≤ 720 mW/cm² and M1 ≤ 1.9 (Track 3, non-ophthalmic); Thermal Index (TI) ≤ 6.0	The system in the modified Flex Focus 1202 is the same as the Flex Focus 1200 and "will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and M1 ≤ 1.9 (Track 3, non ophthalmic). The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0." It also adheres to AIUM/NEMA UD-2 and UD-3.
Clinical Measurement Accuracy	Not explicitly stated as a numerical criterion in the provided text. Implied expectation is that accuracy is maintained consistent with previously cleared devices.	"Clinical measurements and calculations are described and accuracies are provided in the User Information." (No specific values or studies are provided in this document, but implied to be acceptable).
Thermal, Mechanical, and Electrical Safety	Conformance to applicable medical device safety standards, including IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-37, ISO 14971, IEC 62304, IEC 62359. Biocompatibility of patient contact materials.	"The scanner Flex Focus 1202 has been tested by a recognized Certified Body." and "has been found to conform with applicable medical device safety standards." "Cleared patient contact materials, electrical and mechanical safety are unchanged."
RF Wireless Function (New Feature)	No interference with other devices or the ultrasound system itself. Performance to meet "actual user requirements."	"Additional testing of the RF wireless function was performed at five (5) different sites representing actual user requirements. Several test scenarios was performed and no interference was measured."
Technological Equivalence (Overall System)	The device should demonstrate "substantial equivalence" to the identified predicate devices (K081154, K123254) in terms of intended use, modes of operation, indications for use, and technological characteristics. Only minor non-safety/efficacy impacting differences are acceptable.	The document repeatedly asserts substantial equivalence, stating the predicate device has "the same major technological characteristics as the subject device." Minor differences are limited to the optional RF wireless function.

2. Sample Size Used for the Test Set and Data Provenance

Acoustic Output, Thermal, Mechanical, Electrical Safety: No specific "test set" sample size in terms of patient data or image data is mentioned. The testing was likely performed on the device hardware itself following established engineering and safety standards. The provenance is internal testing and certification by a recognized body.
RF Wireless Function: Tested at "five (5) different sites." This refers to locations, and implies device testing rather than patient data.
Clinical Measurement Accuracy: No sample size or provenance is provided in this document; it states details are in "User Information."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information is generally not required or provided for a 510(k) submission seeking equivalence for an existing ultrasound system with minor modifications. The "ground truth" for the performance characteristics discussed (acoustic output, safety, electrical performance) is based on engineering measurements against recognized standards, not expert clinical interpretation of images.

4. Adjudication Method for the Test Set

Not applicable. The reported tests are primarily engineering and safety evaluations against predefined standards, not diagnostic performance assessments requiring clinical adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This 510(k) is aimed at demonstrating substantial equivalence for an updated ultrasound system, not to prove improved clinical effectiveness with or without AI assistance for a specific diagnostic task. The description of the device as an "Ultrasound Scanner" further indicates it's a general imaging tool, not an AI-powered diagnostic aide.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

No, a standalone algorithm performance study was not done. This device is an ultrasound scanner, which is operated by a human. There is no indication of a standalone algorithm component that performs a diagnostic task without human interaction.

7. The Type of Ground Truth Used

Acoustic Output, Thermal, Mechanical, Electrical Safety: Ground truth is established by adherence to international and national device safety and performance standards (e.g., AIUM/NEMA UD-2, UD-3, IEC 60601 series, ISO 14971, IEC 62304, IEC 62359). This involves physical measurements and engineering validation.
RF Wireless Function: Ground truth is implied to be actual user requirements and freedom from interference, measured through testing scenarios.
Clinical Measurement Accuracy: Not explicitly stated, but for a diagnostic ultrasound, this would typically involve phantoms with known dimensions or comparisons to gold standard clinical measurements. The document refers to "User Information" for these details.

8. The Sample Size for the Training Set

Not applicable. This is not a submission for an AI/CADe device that requires a training set. The device is a traditional ultrasound system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device type.

Summary

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K132335
Page 1 of 4

510(k) Summary:

JAN 10 2014 This summary is provided as part of this Premarket Notification in compliance with 21CRF, Section 807.92.

Submitters name: B-K Medical Address: Mileparken 34, 2730 Herlev, Denmark Phone: +45 44528100 Fax: +45 44528199 Contact person: Randi Hauerberg, Regulatory Affairs Lead Manager Date prepared: July 3, 2013

Trade name: Ultrasound Scanner Flex Focus 1202 Common name: Diagnostic Ultrasound System Classification names: (90 IYO, CFR 892.1560) Ultrasonic Pulsed Echo Imaging System Ultrasonic Pulsed Doppler Imaging System (90 IYN. CFR 892.1560) Diagnostic Ultrasonic Transducer (90 ITX, CFR 892.1570)

Identification of predicate, legally marketed device: B-K Medical Ultrasound Scanner Flex Focus 1202, K081154 B-K Medical Ultrasound Scanner Flex Focus 1202, K123254

Device description:

Flex Focus 1202 supports the following scanning modes and combinations thereof: B-mode (incl.Tissue Harmonic Imaging), M-mode, PWD mode, CFM mode, Amplitude (Power) Doppler mode.

The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications.

The system can guide biopsy- and puncture needles.

An optional 3-D module can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

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Transducers

Transducers are linear arrays, convex arrays, phased arrays and mechanical sector. The patient contact materials are biocompatible.

All transducers used together with Flex Focus 1202 are Track 3 transducers.

Acoustic output

The system controlling the Acoustic Output in the modified Flex Focus 1202 is the same as the system in Flex Focus 1200. The system will assure that the acoustic output always will stay below the pre-amendments upper limits i.e. Ispta ≤ 720 mW/cm² and M1 ≤ 1.9 (Track 3, non ophthalmic).

The Thermal Index values are maximum 6.0, i.e. TI ≤ 6.0

Clinical measurement accuracy

Clinical measurements and calculations are described and accuracies are provided in the User Information.

Thermal, mechanical and electrical safety,

The scanner Flex Focus 1202 has been tested by a recognized Certified Body.

Acoustic Output Reporting

The Acoustic Output Reporting is made according to the standards required by "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH. September 9, 2008"

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body.

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Summary of Technological Characteristics - Predicate Device Compared to Modified Device

	Predicate device	Predicate device	Modified device (this application),
	K081154,Ultrasound scannerFlex Focus 1202	K123254,Ultrasound scannerFlex Focus 2202	Ultrasound scannerFlex Focus 1202
Modes of operationRef.: [1] Appendix G	B, M, PWD, CFM 1)and combinationsTissue harmonicimaging.	B, M, PWD, CFM 1)+2) and combinationsTissue harmonicimaging.	B, M, PWD, CFM 1)+2)+3) andcombinationsTissue harmonicimaging.
Intended Use:	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows:	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows:	Diagnostic ultrasoundimaging or fluid flowanalysis of the humanbody as follows:
Indications For Use:	AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-skeletal(conventional andsuperficial)	AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-skeletal(conventional andsuperficial)	AbdominalCardiacFetal (incl Obstetrics)IntraoperativeTransurethralNeurosurgeryPediatricsTransrectalSmall Parts (organs)TransvaginalPeripheral vascularMuskulo-skeletal(conventional andsuperficial)
Features

CFM= Color Flow Mapping=Color Doppler and Amplitude (Power) Doppler.
Includes Vector Flow Imaging
Includes RF wireless function

A brief discussion of non-clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The device has been evaluated for acoustic output, thermal, electrical, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The system complies with the following voluntary standards:

AIUM/NEMA UD-2, Acoustic Output Measurement Standard For Diagnostic Ultrasound . . Equipment
AIUM/NEMA UD-3, Real-time Display of Thermal and Mechanical Acoustic Output . Indices on Diagnostic Ultrasound Equipment
IEC 60601-1, Medical Electrical Equipment, Part 1: General requirements for safety .
IEC 60601-1-1. General requirements for safety, Part 1:1, Collateral Standard, Safety . requirements for medical electrical systems,

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KB32335
Page 4 of 4

IEC 60601-1-2. General requirements for safety, Collateral Standard, Electromagnetic . Compatibility - Requirements and tests
IEC 60601-2-37, Particular requirements for the safety of ultrasonic diagnostic medical . and monitoring equipment
ISO 14971, Application of Risk Management of Medical Devices .
IEC 62304. Medical Device Software Software lifecycle processes .
IEC 62359, Ultrasonics Field characterization Test methods for the determination of . thermal and mechanical indices related to medical diagnostic ultrasonic fields

Cleared patient contact materials, electrical and mechanical safety are unchanged.

Additional testing of the RF wireless function was performed at five (5) different sites representing actual user requirements. Several test scenarios was performed and no interference was measured.

Technological characteristics compared to the predicate device

The predicate device has the same major technological characteristics as the subject device described above.

Minor differences consist: Optional RF wireless function.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 10, 2014

B-K Medical ApS % Mrs. Randi Hauerberg Regulatory Affairs Lead Manager Mileparken 34 Herlev DK-2730 DENMARK

Re: K132335

Trade/Device Name: Ultrasound Scanner Flex Focus 1202 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: November 29, 2013 Received: December 19, 2013

Dear Mrs. Hauerberg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Mrs. Hauerberg

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fdagov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours,

Sm.h.p.)

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K132335

Device Name: Ultrasound Scanner Flex Focus 1202

Indications for Use:

Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD, CWD, Color Doppler, Vector Flow Imaging and combined mode imaging. Signal analysis and display.

Guidance of biopsy needles, geometrical measurements and calculation of parameters. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen.

An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity.

An optional RF wireless function with the ability to wireless transmit for printing and archive connectivity purpose.

Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal, Musculoskeletal.

Details on specific Indication for Use forms

AND/OR Over-The-Counter Use _ Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH Page 1 of 2

Smh.7)

(Division Sign-Off) Division of Radiological Health/OlR 510(k) _______________________________________________________________________________________________________________________________________________________________________ K132335

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Diagnostic Ultrasound Indications for Use Form

System: 1202

Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	8	M	PWD	Tissueamonicimaging	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify 1)	Other4)
Ophthalmic
Fetal 2) (K081154)		P	P	P	P	P	P		P
Abdominal {K081154}		P	P	P	P	P	P		P
Intraoperative(specify)(K081154)		p	P	p	P	P	P		P
IntraoperativeNeurological(K081154)		P	P	P	P	P	P		P
Pediatric (K081154)		P	P	P	P	P	P		P
Small(specify)Organ(K081154)		P	P	P	P	P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac (K081154)		P	P	p	P	P	P		P
Transesophageal
Transrectal (K081154)		P	P	P	P	p	P		P
Transvaginal (K081154)		P	P	P	P	P	P		P
Transurethral (K081154)		p	P	P	P	P	P		p
Intravascular
PeripheralVascular(K081154), (K123254 )		ರಿ	P	P	P	p™	P		P
Laparoscopic
Musculo-skeletalConventional (K081154)		P	P	P	P	P	P		P
Musculo-skeletal Superficial(K081154)		P	p	P	P	P	P		P
Other (specify)RF Wireless										N"

N= new indication; P= previously cleared by FDA; E= added under Appendix E

Additional Comments:__________________________________________________________________________________________________________________________________________________________

B+M, B+D. B+C, B+D+C. B mode includes Tissue Harmonic Imaging

D is PWD, C is Color Doppler.

Fetal is often called Obstetrics ਨੀ

Vector Flow Imaging 3)

RF wireless function 4)

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH

Page 2 of 2

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.